On January 11, 2021 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and the National Cancer Institute (NCI), part of the National Institutes of Health, reported that have established a research collaboration aimed at testing mesothelin-targeting therapies for the treatment of cancers where humoral immunity is suppressed (Press release, Navrogen, JAN 11, 2021, View Source [SID1234573806]).

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Mesothelin is a cell surface protein over-expressed on various malignancies, including lung cancer and mesothelioma. Certain therapeutic antibodies that use humoral immune function to kill cancer cells as well as antibody-drug conjugates (ADCs) targeting mesothelin are negatively affected by Humoral Immuno-Oncology (HIO) factors that are produced in the tumor microenvironment. To overcome this mechanism of HIO suppression, Navrogen has employed its proprietary HIO factor screening and block-removed immunoglobulin technology (BRITE) to engineer HIO refractory mesothelin-targeting agents.

The collaboration with the Thoracic and GI Malignancies Branch at NCI’s Center for Cancer Research, led by Raffit Hassan, M.D., is a joint effort to analyze ADCs for in vivo efficacy against human mesothelioma models developed by the Hassan laboratory. A major focus of the Hassan laboratory is developing mesothelin-targeted agents for treating cancer to include the development of mesothelioma patient-derived xenografts that mimic the molecular characteristics of patient tumors. Navrogen and NCI will combine their expertise and experimental resources to enable the comprehensive characterization of mesothelin targeting ADCs as agents for future human studies against mesothelin-expressing cancers including mesothelioma.

"We have engineered a HIO-refractory anti-mesothelin ADC (NAV-001) that will be tested in collaboration with NCI researchers by employing their patient-derived tumor models that are clinically relevant to mesothelioma and lung cancer," commented Dr. Luigi Grasso, Navrogen’s Chief Scientific Officer. "Results of these studies will aid in determining optimal dosing and tumor subtypes for Navrogen to pursue clinically".

On January 11, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in January (Press release, MacroGenics, JAN 11, 2021, View Source [SID1234573805]):

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H.C. Wainwright & Co. BioConnect 2021 Conference. A corporate overview provided by MacroGenics’ management will be available for on-demand viewing from January 11 – 14, 2021. In addition, MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion on Precision Medicine hosted by Scott Gottlieb, M.D., Former Commissioner of the U.S. Food and Drug Administration. The panel will cover the importance of biomarkers and cytogenetic profiling in drug discovery, development and commercialization and will take place on Wednesday, January 13, 2021, at noon ET.
39th Annual J.P. Morgan Healthcare Conference. MacroGenics’ management will participate in one-on-one meetings and provide a corporate overview on January 14, 2021 at 10:00 AM ET.
Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

On January 11, 2021 Cerus Corporation (Nasdaq: CERS) reported preliminary product revenue for the fourth quarter and full year 2020 and provided 2021 product revenue guidance (Press release, Cerus, JAN 11, 2021, View Source [SID1234573804]).

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Cerus’ unaudited preliminary product revenue for the fourth quarter of 2020 totaled $28.2 million, an increase of 35% over the $20.9 million recognized during the same period in the prior year. Based on its fourth quarter unaudited preliminary product revenue, the Company expects full year 2020 product revenue of $91.9 million, exceeding the Company’s current 2020 product guidance range of $89 million to $91 million. The preliminary product revenue results have not been audited and are subject to change.

Preliminary fourth quarter product revenue would represent the highest quarterly product revenue ever reported by Cerus.

"Despite the challenges that our blood center customers, hospitals and we have faced with the COVID-19 pandemic, demand for INTERCEPT continues to grow impressively. While we anticipate that COVID-19 may still impact our access to blood centers and hospitals in the U.S. and western Europe in 2021, we nonetheless expect to see continued growth in INTERCEPT platelet kit demand, particularly in the U.S. as the new October 1 deadline for compliance with the FDA guidance on bacterial safety approaches," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

"2021 will also mark our first sales of a biologic therapeutic product – Pathogen Reduced Cryoprecipitated Fibrinogen Complex. Our initial, limited launch will be a building phase ahead of a much broader, nationally focused rollout we expect in 2022. Based on our interactions and work to date, we are encouraged by the clinician reception to the new product and look forward to introducing the first manufactured products to hospitals for transfusion to patients this year," continued Greenman.

Despite ongoing pandemic-related customer access limitations, the Company expects full year 2021 product revenue will be in the range of $106 million to $110 million, representing growth of approximately 15% to 20% compared to preliminary unaudited 2020 full year results. This growth is expected to be driven by strong platelet kit demand in the U.S., as well as expected continued market adoption in targeted international markets.

Cerus will provide complete fourth quarter and full year 2020 financial results and host a call to discuss both 2020 results and 2021 expectations in late February.

On January 11, 2021 UroGen Pharma Presented the Corporate Presentation (Press release, UroGen Pharma, JAN 11, 2021, View Source [SID1234573803]).

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On January 11, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has entered into a securities purchase agreement with certain institutional investors, providing for the purchase and sale of 1,810,000 shares of common stock at a price of $8.30 per share, priced at-the-market under Nasdaq rules, in a registered direct offering, resulting in total gross proceeds of approximately $15 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, JAN 11, 2021, View Source [SID1234573801]).

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The offering is expected to close on or about January 13, 2021, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, for research and development, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.